Cangene’s Antidote for Terrorism Toxin Works, FDA Staff Says

Cangene Corp.’s animal studies on an
experimental antidote for a toxin considered a bioterrorism
threat are sufficient enough to suggest the treatment will work
in humans, U.S. regulators said.

The antitoxin for botulism is safe and the benefits exceed
the risks, Food and Drug Administration staff said today in a
report ahead of a meeting Feb. 12 of agency advisers to discuss
the product. Cangene, based in Winnipeg, Canada, currently
supplies the antitoxin to the U.S. government under an exemption
for use in an emergency situation.

The company is now seeking FDA approval based on safety
studies in humans, as well efficacy studies in guinea pigs and
monkeys. The U.S. government awarded Cangene in 2006 a contract
now valued at $476 million for late-state development of the
antitoxin and 200,000 doses, according to the arm of the
Department of Health and Human Services responsible for the
nation’s approach to preparing vaccines and drugs for national
emergencies.

The FDA may decide on Cangene’s application for approval by
March 20, according to the staff report.

Bioterror Weapon

Cangene fell 1.2 percent to C$2.55 at 9:30 a.m. in Toronto
trading. The shares gained 43 percent in the 12 months through
yesterday.

Botulism causes paralysis that can lead to death once the
airway and breathing muscles stop moving. An average of 110
cases of botulism are reported each year, according to the
Occupational Safety and Health Administration.

The botulinum toxin can be used as a bioterror weapon if
deliberately released as an aerosol or in food or drink.
Naturally occurring cases can occur in food or drink as well,
often in inadequately canned foods, and contaminated wounds,
according to the Center for Biosecurity of the University of
Pittsburgh Medical Center in Baltimore, Maryland.

In the study on the monkeys, 14 of 30 that received the
Cangene antitoxin survived compared to none out of 30 in a
placebo group that had been intoxicated with botulism.

Cangene reported $111 million in revenue for the fiscal
year ended in July.